Healthcare & Life Sciences, ENSafrica updates

South Africa

Contributed by ENSafrica
Bolar provisions for generic and biosimilar medicines
  • South Africa
  • 14 August 2019

South Africa is in the process of reviewing all existing IP laws, particularly in the context of access to medicines. It appears that the type of changes to be made in respect of the Bolar exception will relate to whether the narrow exception should be extended and, if so, to what. In particular, it is likely that an early experimental research exclusion will be included, such as for pre-clinical research. It remains to be seen whether South Africa's laws may change to allow stockpiling of generic medicines.

New breeding techniques and regulation of genetically modified organisms
  • South Africa
  • 15 May 2019

A recent European Court of Justice ruling on the status of organisms obtained by new breeding techniques as genetically modified organisms (GMOs) has again brought the scope of the South African GMOs Act into question. The difficulty with regulating organisms created through such techniques is that these organisms may be indistinguishable from organisms which have naturally evolved.

Medical cannabis: growing pot-ential
  • South Africa
  • 05 December 2018

Cannabis has enjoyed heightened attention following a recent ruling decriminalising the private possession, consumption and cultivation of the plant for recreational purposes. While there have been several positive developments in the promotion of the medical cannabis market in South Africa, the overarching regulatory framework and authorities' current practice remain barriers to entry for prospective local players in the medical cannabis product manufacturing market.

Bioprospecting and biotrade requirements
  • South Africa
  • 03 October 2018

The Biodiversity Act regulates bioprospecting on and biotrade with indigenous biological resources and indigenous genetic resources and the use of traditional knowledge. Although the early years of regulation under the act were stormy and there was much confusion over who needed to apply for permits and what was required from applicants, there is now more certainty as to what is required.

Ownership of genetic information and tissue under National Health Act
  • South Africa
  • 08 August 2018

The legal and philosophical issues relating to the concept of ownership of various kinds of human biological material has been hotly debated. This is an emotive topic that requires balancing societal and commercial interests with individuals' rights, such as the constitutional right to bodily and psychological integrity, which includes the right not to be subjected to medical research or scientific experiments without giving informed consent.


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